Regulatory Affairs Specialist

Date: Jun 9, 2021

Location: Bogota, CUN, CO

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 3911

 

About Teleflex Incorporated

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

 

Latin America - The Latin America Region of Teleflex is headquartered in Morrisville, North Carolina, and supports our customers, distributors, sales managers and specialists in Mexico, Brazil, Colombia, Chile, Argentina and Puerto Rico. The Latin America Region sells a broad spectrum of medical devices and related products in the fields of vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care. As Teleflex grows and expands its portfolio, we will continue to grow our presence in Latin America.  Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

This is a mid-level regulatory affairs position that requires the ability to leverage regulatory knowledge
throughout the product registration process with effective project coordination. The position supports the Regulatory Affairs function and the organization by communicating regulatory strategies and preparing the regulatory documentation necessary to support market authorizations in Colombia. 
 

Principal Responsibilities

Assist Regulatory Affairs function, through the following activities:
•    Understand regulatory processes, guidelines and guidance documents and the impact to the organization.
•    Understand and apply quality management system knowledge to all activities.
•    Conduct appropriate research to develop strong regulatory strategies.
•    Monitor Colombian regulations/guidelines and the impact of changing/evolving regulations on submissions, practices and procedures and communicate to appropriate stakeholders.
•    Participate on multidisciplinary teams and communicate regulatory requirements effectively.
•    Evaluate regulatory impact of proposed design and manufacturing changes to commercially distributed medical devices. 
•    Interface with various departments and platforms to collect and organize required documentation materials.
•    Determine issues which may create regulatory obstacles and investigate solutions.
•    Prepare, review and submit applicable regulatory documentation as required for Colombian market.
•    Monitor progress of submission reviews and interact with regulatory consultants, authorized distributors, local business entities and/or regulatory agencies, as appropriate.
•    Maintain electronic and paper regulatory files, as required.
•    Support regulatory and compliance initiatives/requirements.
•    Assist in device import/export activities, as needed.
•    Deliver regular updates of all relevant regulatory activities to the Manager of Regulatory Affairs Mexcio, Colombia & Chile.
•    Provide other department support as required by immediate supervisor.
•    Train, develop and mentor Regulatory Affairs team members, as appropriate.
•    Adhere to and ensure the compliance of Teleflex’s Code of Ethics, all company policies, rules, procedures, and housekeeping standards.
 

Education / Experience Requirements

•    Bachelor’s degree in a device-related discipline such as life sciences or engineering
•    Minimum 1-3 years with regulatory medical device experience, in Colombia
•    Languages – Fluent in English and Spanish, both written and oral
•    Experience in working with and interfacing with INVIMA
•    Demonstrates strong success rate of device submissions/approvals for Class I - III (materials and equipment). Should have experience with technical files/design dossiers in the EU.
 

Specialized Skills / Other Requirements

•    Strong communication skills (verbal and technical writing)
•    Strong attention to detail
•    Strong analytical and critical thinking skills
•    Ability to organize, prioritize, manage multiple projects and meet deadlines 
•    Orientation to teamwork, problem solving ability, customer focus, and a commitment to quality
•    Knowledge of electronic document management systems 
•    Ability to apply Business and Regulatory Affairs ethical standards 
•    Proficiency in MS Word, Excel, Power Point, and Outlook 
 

 

Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® – trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

© 2021 Teleflex Incorporated. All rights reserved.